Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 18 of 33 for:    Recruiting, Not yet recruiting, Available Studies | obesity | stimulation

Responsive Neurostimulation For Loss Of Control Eating (DBSLOC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03868670
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : March 11, 2019
Sponsor:
Collaborator:
NeuroPace
Information provided by (Responsible Party):
Casey H. Halpern, Stanford University

Tracking Information
First Submitted Date  ICMJE February 14, 2019
First Posted Date  ICMJE March 11, 2019
Last Update Posted Date March 11, 2019
Estimated Study Start Date  ICMJE February 27, 2019
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2019)
  • Incidence of Treatment-Emergent Related Adverse Events [Safety and Tolerability] [ Time Frame: 5 years ]
    Safety of the RNS System and NAc stimulation through evaluation of AE's graded as "related" (vs. not related) to the intervention that will be graded based on severity. Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE
  • Count of Participants Exhibiting Overall Decrease in Loss of Control Episodes Per Week [ Time Frame: 5 years ]
    This endpoint will be met if at least 50% of subjects exhibiting a decrease in the number of Loss of Control (LOC) episodes per week. LOC episodes will be assessed by the currently available standard, ecological momentary assessment (EMA) diary entries.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Responsive Neurostimulation For Loss Of Control Eating
Official Title  ICMJE Responsive Neurostimulation For Loss Of Control Eating
Brief Summary The primary objective of this trial is to assess device function and safety, with secondary objectives including the feasibility.
Detailed Description This is a single site, early feasibility study to support development of a novel therapeutic approach for utilizing the NeuroPace RNS® System for nucleus accumbens responsive neurostimulation (NAc- RNS) to ameliorate loss of control over (LOC) eating in persons with treatment-refractory obesity, specifically those who have failed gastric bypass surgery. The primary objectives are to assess the safety & feasibility & potential efficacy of the medical device named the NeuroPace RNS® System
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE
  • Loss of Control Eating
  • Obesity, Morbid
Intervention  ICMJE Device: responsive neurostimulation
The RNS® System is a novel, implantable therapeutic device that delivers responsive neurostimulation, an advanced technology designed to continuously monitor brain electrical activity, detect abnormal electrical activity and respond by delivering imperceptible levels of electrical stimulation to normalize that activity before an individual experiences seizures. This is an Early Feasibility Study determining the safety and efficacy of NAc-RNS in the treatment of LOC eating in treatment-refractory obesity.
Study Arms  ICMJE Experimental: Responsive Neurostimulation
Surgical arm. Patients expected to receive treatment.
Intervention: Device: responsive neurostimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 6, 2019)
6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2025
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI 45-60 kg/m2
  • Failure of at least one weight loss medication
  • Previous Gastric Bypass Surgery lead to less than 50% of excess weight lost by 2 years after surgery
  • Significant Loss of Control over eating
  • Subject is able to attend all scheduled clinic appointments on their own or with a caregiver.
  • Premenopausal women must agree to use acceptable methods of birth control.
  • Participants provide voluntary, decisionally capable, and appropriately informed consent.
  • Subject is able to comply w/ all testing and follow-up requirements defined by the study protocol.
  • Participant has no immediate plan for relocation beyond 6 hours of the study site.
  • Proficiency with the English language.

Exclusion Criteria:

  • Subject has an implanted medical device that delivers electrical energy to the brain.
  • Subject has an implantable cardiac pacemaker, defibrillator, or neurostimulator.
  • Subject is likely to require repeat MR imaging after implant of the RNS Neurostimulator and Leads.
  • Subject is unable to fit into CT scanner (500lb upper weight limit for CT scanner).
  • Inability to provide informed consent to treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vyvian Ngo, BS, MPH 650-498-0817 vyviann@stanford.edu
Contact: Emma Adair, BS eadair@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03868670
Other Study ID Numbers  ICMJE IRB-46563
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Casey H. Halpern, Stanford University
Study Sponsor  ICMJE Casey H. Halpern
Collaborators  ICMJE NeuroPace
Investigators  ICMJE Not Provided
PRS Account Stanford University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP